Senior Manufacturing Engineer

Description

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The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers.  While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.  

About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.      

Job Purpose:

Responsible for activities and area goals through qualification, deployment, and sustaining at the component and   finished product level;

Duties and Responsibilities

•  Support production monitoring with in-process test execution and trending;
• Define appropriate alert and action limits based on process performance;
• Maintain effectiveness of manual test methods through training and certification process;
• Assess equipment and process for ergonomics and safety;
• Partner with appropriate vendors to design tooling for production fixturing;
• Identify system-process interactions using standard tools (p-diagram, SIPOC, VSM);
• Design or modify existing equipment and fixtures for usability and robustness in manufacturing;
• Maintain equipment related documentation (manuals, drawings, specifications);
• Complete line replication and re-qualification activities to support demand, including at key suppliers;
• Maintain risk documentation (PFMEA) for new failure modes and mitigations;
• Coordinate with Planning to manage build schedule and material allocation per demand;
• Provide guidance and training to operators on engineering and V&V builds, as needed;
• Confirm team comprehension of builds requests, redlines, and special instructions; 
• Develop sustaining cost model for lab supplies, consumables, fixtures, and spare parts;
• Collect time measurements and process videos to baseline headcount needs;
• Provide voice of manufacturing to ensure successful transfer from R&D to production;
• Remediate build documentation for clarity and standardization;
• Develop hands-on training materials for critical processes and equipment (pipetting, etc.);
• Develop job aids and other guidance documents to support process adherence;
• Provide technical training to operators for assigned equipment and processes;
• Identify and implement mistake-proofing opportunities;
• Participate in daily meetings to review build plan, metrics, and escalations needing support;
• Complete standard work activities to monitor production status and identify gaps;
• Complete periodic work (equipment setup, test verification, etc.) to support build plan;
• Maintain equipment status (preventative maintenance, corrective maintenance, spare parts) to minimize line disruption (OEE); Revise schedule and activities as appropriate based on history and risk;
• Monitor and replenish inventory levels of production materials, fixtures, and supplies;
• Submit purchase requisitions for items required by manufacturing and engineering projects;
• Support 5S adherence in manufacturing by completing routine audits and identified actions;
• Resolve technical or logistics issues impacting build delivery;
• Complete root cause investigation and actions for non-conformances (NCMR, CAPA, SCAR);
• Monitor production performance through control charting, reject pareto, and review of process capability (SPC);
• Maintain up-to-date model data (manual time, auto time, cost) for assigned processes;
• Share performance trends, insights, and strategic insights with cross-functional team for alignment;
• Develop data collection and integration processes for visibility to production status;
• Support facility expansion, site transfer, and capacity planning activities;
• Optimize processes for quality, efficiency, and process repeatability at the lowest cost;
• Complete standardized work and line balancing activities to optimize production output;
• Utilize problem solving techniques to identify root causes to technical issues (rejects, equipment availability, etc.) and implement sustainable countermeasures to address them;
• Investigate device observations and field complaints related to manufacturing process;
• Collaborate with R&D, Supply Chain, and Quality to drive actions, priorities, and trade-offs required to meet targeted COGS;
• Complete change impact assessment to align implementation plan for proposed changes;
• Evaluate and implement 2nd source vendors for manufacturing supply risk;
• Define appropriate lot size and packaging format for raw materials to scale with demand;
• Integrate external and internal processes to optimize end-to-end supply chain;
• Transfer peripheral processes and subassemblies to contract manufacturing sites;
• Manage manufacturing activities and project execution with external vendors;
• Support communication, collaboration, and strategic relationship with key suppliers;
• Develop business processes, infrastructure, and tools to improve manufacturing execution;

Requirements

• BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
• Minimum 5-8 years related experience, including years of higher-level education (MS, PhD)
• Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
• Experience with Fishbone, A3, 5Y, and other root cause investigation tools
• Experience in high-volume manufacturing operations within medical device, electronics, or biotechnology industries
• General understanding of system interactions and interdependencies between processes
• Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
• Experience with lean manufacturing and six sigma methodologies (preferred)
• Experience with design for manufacturability concepts and product development lifecycle (preferred)
• Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
• Proficiency in developing and delivering technical and executive-level presentations.  Promotes alignment, action, and accountability framework within working teams
• Proficiency in Microsoft Office tools
• Proficiency with JMP,   Minitab, or equivalent statistical software
• Experience with ERP, MES, and other manufacturing systems
• Proficiency in BMRAM or equivalent asset management system
• Expertise in one or more specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
• Proficiency in Solidworks or equivalent CAD software (preferred)
• Experience with MS Project, Visio, and other project management tools (preferred)
• Fosters a positive and inclusive work environment. Engages in productive conflict with thoughtful questioning
• Proactively identifies roadblocks and implements mitigations to minimize disruptions. Builds more efficient processes and finds better ways
• Sustained reliability, transparency, and integrity. Strong resiliency when faced with challenges
• Ability to come up to speed quickly, navigate uncertainty, and make timely decisions. Ability to condense complex requirements into specific and measurable objectives
• Strong quality-orientation with attention to detail and a desire to deliver service excellence. Bias for action, acts with urgency to deliver work that adds value

Working Conditions

General Office, Laboratory, and Cleanroom environments

Expected travel less than 10%

Physical Requirements

While performing the duties of   this job, the employee is regularly required to stand; walk; sit; use hands to   handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may   occasionally lift/or move up to 15 pounds.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process.  The U.S. base salary range reasonably expected to be paid for this role is: $110,000 to $125,000 per year.  We may ultimately pay more or less than the posted range.  Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S.  The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans.  Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties.  Your recruiter can share more about the total compensation package during the hiring process.  

Please note:  The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.  Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time.  The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at [email protected]